DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration[Docket No. 01D-0276]Guidance for Industry: Channels of Trade Policy for Commodities With Vinclozolin Residues; AvailabilityAGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a final guidance document for industry entitled “Channels of Trade Policy for Commodities With Vinclozolin Residues.” This guidance presents FDA's policy for implementing, for the pesticide chemical vinclozolin, the channels of trade provision in the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food Quality Protection Act (FQPA) of 1996. The guidance is intended to assist firms in understanding FDA's planned approach to the enforcement of this provision of the FQPA with regard to residues of vinclozolin in food.

DATES:

Submit written or electronic comments concerning the guidance at any time.

ADDRESSES:

Submit written comments concerning the guidance document to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Submit written requests for single copies of the guidance document entitled “Channels of Trade Policy for Commodities With Vinclozolin Residues” to the Office of Plant and Dairy Foods and Beverages (HFS-305), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to this document.

In a notice published in the Federal Register of July 10, 2001 (66 FR 35990), FDA announced the availability of a draft guidance document entitled “Channels of Trade Policy for Commodities With Vinclozolin Residues.” The agency has finalized the draft guidance after receiving no comments on the document. In a notice published in the Federal Register of October 23, 2001 (66 FR 53614), FDA announced that it was submitting to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 the collection of information entitled “Suggested Documentation for Demonstrating Compliance With the Channels of Trade Provision for Foods With Vinclozolin Residues.” In the October notice, FDA estimated that the guidance entitled “Channels of Trade Policy for Commodities With Vinclozolin Residues” would create an estimated annual reporting burden of 921 hours and an estimated annual recordkeeping burden of 496 hours. The October notice also requested comments on these burden estimates. On March 25, 2002, OMB informed FDA that it had approved the information collection until March 31, 2005.

II. Guidance Document

This final guidance document is being issued as level 1 guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on the channels of trade provision and how this provision relates to FDA-regulated products with residues of vinclozolin. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.

III. Electronic Access

Copies of this guidance also may be downloaded to a personal computer with access to the Internet. The final guidance document may be accessed at http://www.cfsan.fda.gov under “How to Obtain FDA Food & Cosmetic Guidance Documents.”

IV. Comments

Interested persons may, at any time, submit written comments concerning the guidance entitled “Channels of Trade Policy for Commodities With Vinclozolin Residues” to the Dockets Management Branch (see ADDRESSES). Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. A copy of the guidance is available for public examination in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.